U.S. patent application number 12/899132 was filed with the patent office on 2012-01-12 for garment to facilitate electrode placement for intraoperative monitoring.
This patent application is currently assigned to ProNerve, LLC. Invention is credited to James Higgins, Jeff Thramann.
Application Number | 20120010492 12/899132 |
Document ID | / |
Family ID | 45439074 |
Filed Date | 2012-01-12 |
United States Patent
Application |
20120010492 |
Kind Code |
A1 |
Thramann; Jeff ; et
al. |
January 12, 2012 |
GARMENT TO FACILITATE ELECTRODE PLACEMENT FOR INTRAOPERATIVE
MONITORING
Abstract
A garment is provided with an electrode and indicia to
facilitate placement of the garment. The indicia is used to orient
the garment such that the electrode is placed in precise
orientation with respect to a stimulation site to facilitate
intraoperative monitoring during surgical procedures.
Inventors: |
Thramann; Jeff; (Longmont,
CO) ; Higgins; James; (Phoenix, AZ) |
Assignee: |
ProNerve, LLC
Broomfield
CO
|
Family ID: |
45439074 |
Appl. No.: |
12/899132 |
Filed: |
October 6, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12831708 |
Jul 7, 2010 |
|
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12899132 |
|
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Current U.S.
Class: |
600/388 ;
600/554 |
Current CPC
Class: |
A61N 1/0484 20130101;
A61B 5/6806 20130101; A41D 13/1236 20130101; A61B 5/296 20210101;
A61B 5/291 20210101; A61N 1/0502 20130101; A61B 5/684 20130101;
A61B 5/6803 20130101; A61B 5/377 20210101; A61B 5/24 20210101; A61B
5/6804 20130101 |
Class at
Publication: |
600/388 ;
600/554 |
International
Class: |
A61B 5/053 20060101
A61B005/053; A61B 5/04 20060101 A61B005/04 |
Claims
1. A garment to facilitate the precise location of surface
electrodes adapted to provide a stimulating signal to a nerve to
facilitate intraoperative evoked potential monitoring during a
surgical procedure comprising: a fabric comprising a skin surface
and a top surface, the skin surface adapted to be positioned on a
portion of the skin on a patient; at least one electrode adapted to
contact the skin of the patient, the at least one electrode
positioned on the fabric and arranged such that when placed on the
skin of the patient, the at least one electrode is configured to be
in proximity to a stimulation site the stimulation site selected
from the group of stimulation sites consisting of: a nerve, a
muscle, or a combination thereof; and at least one indicia on the
fabric, the at least one indicia on the fabric providing to provide
orientation for the fabric such that the at least one electrode is
adapted to be orientated in proximity to the stimulation site,
wherein the fabric is adapted to be fitted such that any operating
room personnel may perform the application
2. The garment of claim 1, wherein the at least one electrode is
selected from a group of electrodes consisting of: a needle
electrode, a surface electrode, or a combination thereof.
3. The garment of claim 1, wherein the fabric comprises a plurality
of strips.
4. The garment of claim 1, wherein the fabric comprises a garment
adapted to be worn by a patient, the garment selected from a group
of garments consisting of: a glove, a wrist band, a skull cap, a
shirt, a legging, a pair of leggings, a pair of pants, a full body
suit, a neck wrap, or a combination thereof.
5. The garment of claim 1, wherein the fabric comprises a fabric
selected from the group of fabrics consisting of: a gauze, a
rubber, a foam, a wrap, a cloth, an elastic stocking, or a
combination thereof.
6. The garment of claim 3, wherein the plurality of strips comprise
an adhesive on the skin surface adapted to adhere the plurality of
strips to the skin.
7. The garment of claim 6, wherein the adhesive is a conductive
adhesive.
8. A method of placing at least one electrode for intraoperative
monitoring of a patient comprising the steps of: providing a
garment having a skin surface adapted to contact the skin of a
patient with at least one electrode on the skin surface; arranging
the garment on the patient such that the at least one electrode is
configured to be oriented in proximity to a simulation site the
stimulation site being selected from a group of stimulation sites
consisting of: a nerve, a muscle, or a combination thereof during
an intraoperative monitoring procedure; performing the
intraoperative monitoring procedure; and removing the garment.
9. The method of claim 8 further comprising the step of aligning
indicia on the garment with the patient to orient the at least one
electrode such that the at least one electrode is configured to be
in proximity to a nerve to be stimulated.
10. The method of claim 9 wherein the step of aligning the indicia
comprises aligning a wrist, palm, and thumb portion of a glove on a
patient.
11. The method of claim 9 wherein the step of aligning the indicia
comprises aligning a knee portion of a legging on a patient.
12. The method of claim 9 wherein the step of aligning the indicia
comprises aligning a forearm portion of a sleeve on a patient.
13. The method of claim 9 further comprising the step of
manipulating the garment during the surgical procedure.
14. The method of claim 13 wherein the step of manipulating the
garment during the surgical procedure comprises removing portions
of the garment during the surgical procedure.
15. A garment to facilitate the orientation of at least one
electrode to stimulate a nerve during a surgical procedure
comprising: a fabric adapted to be worn by a patient having a skin
surface adapted to reside proximate to the skin of a patient and a
top surface opposite the skin surface; a surface electrode arranged
on the skin surface of the fabric; and means for orienting coupled
to the top surface the fabric to orient the fabric on the patient
such that the surface electrode is configured to be proximate a
nerve to be stimulated during the surgical procedure.
16. The garment of claim 15 wherein the means for orienting
comprises orifices in the fabric adapted to fit at least one body
part of the patient.
17. The garment of claim 16 wherein the orifice is selected to fit
at least one body part selected from the group of body parts
consisting of: a wrist, a finger, a thumb, a forearm, an elbow, a
shoulder, a bicep, a neck, a head, a face, a leg, a knee, a foot,
an ankle, a knuckle; or a combination thereof.
18. The garment of claim 15 wherein the means for orienting
comprises at least one marking on the top surface.
19. The garment of claim 16 wherein the means for orienting further
comprises at least one marking on the top surface.
20. The garment of claim 1 wherein the garment comprises additional
devices to facilitate a medical procedure.
Description
CLAIM OF PRIORITY UNDER 35 U.S.C. .sctn..sctn.119, 120
[0001] The present application for patent is a continuation in part
of U.S. patent application Ser. No. 12/831,708, titled GARMENT TO
FACILITATE NEEDLE ELECTRODE PLACEMENT FOR INTRAOPERATIVE
MONITORING, filed Jul. 7, 2010, and incorporated by reference as if
set out in full.
REFERENCE TO CO-PENDING APPLICATIONS FOR PATENT
[0002] The present Application for Patent is related to co-pending
U.S. patent application Ser. No. 12/724,778, titled Somatosensory
Evoked Potential (SSEP) Automated Alert System, filed Mar. 16,
2010, and incorporated herein by reference as if set out in
full.
BACKGROUND
[0003] 1. Field
[0004] The technology of the present application relates generally
to intraoperative monitoring (IOM), and more specifically, to
garments and methods of using the garments to facilitate placement
of needle or surface electrodes for IOM.
[0005] 2. Background
[0006] During surgery, nerve damage is possible for a number of
reasons. For example, one potential complication from surgery may
include peripheral neuropathy related to surgical positioning that
may in some cases be generally known as an iatrogenic injury.
Intraoperative positioning nerve injuries are complications from
surgery that may occur from extension or compression of peripheral
nerves.
[0007] Nerve injuries may be preventable by monitoring nerves or
muscle groups innervated by the nerves for degradation of
conductivity or the like. Even though preventable in many
instances, peripheral nerve injuries still occur during
surgery.
[0008] Because positioning injuries occur, some surgeries include
intraoperative monitoring ("IOM"). The goal of IOM is to identify
changes in brain, spinal cord, and peripheral nerve function prior
to irreversible damage occurring.
[0009] IOM typically includes using an evoked potential such as,
for example, somatosensory evoked potentials (SSEP), brain stem
auditory evoked potentials (BAEP), motor evoked potentials (MEP),
and visual evoked potentials (VEP). Generally, the activity
associated with evoked potentials are elicited/evoked from a
time-locked peripheral stimulus, such as, for example, stimulus to
the arms/legs for SEP, noise in the ear for BAEP, or light for
VEPs. Electromyography (EMG) recording of induced or mechanical
muscle activation is also is used extensively during operative
cases. Scalp electroencephalography (EEG) provides data for
analysis of more spontaneous global electrocortical activity. Scalp
EEG also can be used to monitor cerebral function during carotid or
other vascular surgery. In addition, EEG recorded directly from the
pial surface, or electrocorticography (ECoG), is used to help
determine resection margins for epilepsy surgery, and to monitor
for seizures during electrical stimulation of the brain carried out
while mapping cortical function.
[0010] Looking specifically at SSEP, SSEPs are recorded by
stimulating peripheral afferent nerves, usually electrically, and
the responses are recorded with the help of scalp electrodes.
Because of the presence of nonspecific EEG background activity, the
evoked potential must be time-locked to the stimulus and averaged
to improve signal-to-noise ratio.
[0011] In intraoperative use, the median, or ulnar nerves, at the
wrist are the most common stimulation site for upper extremity
monitoring. In the lower extremity, the posterior tibial nerve just
posterior to the medial malleolus, or common peroneal at the
politeal fossa, are used most commonly. Alternative sites of
stimulation along the path of the peripheral nervous system also
may be used.
[0012] Needle electrodes generally are used as they are easier to
apply than, for example, surface electrodes that would require the
skin to be prepared prior to use. Recording electrodes are placed
on the scalp over the correlate sensory cortical areas and over the
lumbar and cervical spine. Additionally, electrodes can be placed
at the Erb's point for upper extremity SSEP recording and over the
politeal fossa for lower extremity recording. A correlation to
Erb's point for lower extremity is the popliteal fossa at the back
of the knee. The readings are to confirm that stimulus is being
delivered.
[0013] FIG. 1 shows a typical measure SSEP waveform 100. Waveform
100 is known as an N20 waveform and relates to the negative peak of
the potential occurring at approximately 20 milliseconds. The
waveform 100 was generated by a peripheral nerve stimulator using a
constant current stimulus output applied to the wrist of a patient.
Other types of stimulators are possible as well, such as, for
example, a voltage based stimulator, a magnetic based stimulator,
etc. The waveform 100 was the measured response by an electrode
placed on the skin surface or subdermally of the patient's head. In
this case, an electrode 200 was placed about 4 cm up and 2 cm back
from the top of the ear 202 of the patient 204 as shown in FIG.
2.
[0014] As can be appreciated, placement of the electrodes in the
patient is a part of IOM. A certified or skilled IOM technician
must be on-site in the operating room to insert the needle
electrodes properly into the patient using conventional
methodologies. The on-site skilled IOM technician increases the
cost of IOM and often results in many surgeries being conducted
without IOM due to their cost and lack of availability in some
areas. In some instances, nerve injury may be prevented if IOM had
been available. Therefore, there is a need in the art for devices,
apparatuses, methods, and the like to facilitate placement of
needle electrodes in IOM.
SUMMARY
[0015] Embodiments disclosed herein address the above stated needs
by providing a garment having needle electrodes. The garment
facilitates the implantation of needle electrodes for
intraoperative monitoring during a surgical procedure. The garment
is made from a fabric having a thickness separating a skin surface
adapted to reside proximate to the skin of a patient and a top
surface opposite the skin surface. At least one tube resides in the
fabric between the skin surface and the top surface, the tube has a
stop. A needle electrode cooperatively engages the tube such that
the tube is adapted to receive the needle electrode and the needle
electrode is adapted to be inserted through the skin of the
patient. The needle electrode cooperatively engages a stop such
that the needle electrode will be positioned proximate a nerve or
muscle to be monitored or stimulated.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is an exemplary waveform relating to a sensory evoked
potential (SEP);
[0017] FIG. 2 is a functional block diagram showing a system useful
in measuring the SEP of a patient;
[0018] FIG. 3 is a diagram of representative anatomy associated
with an arm and hand;
[0019] FIG. 4 is a top plan view of a garment consistent with the
technology of the present application;
[0020] FIG. 5 is a partial cross-sectional view of the garment of
FIG. 4 consistent with the technology of the present
application;
[0021] FIG. 6 is a partial cross-sectional view of the tube of FIG.
5 consistent with the technology of the present application;
[0022] FIG. 7 is a partial cross-sectional view of the tube of FIG.
5 consistent with the technology of the present application;
[0023] FIG. 8 is a partial cross-sectional view of the tube and
cover consistent with the technology of the present
application;
[0024] FIG. 9 is a partial cross-sectional view of the tube and
cover consistent with the technology of the present
application;
[0025] FIG. 10 is an illustrative flowchart exemplary of one method
of performing operations consistent with the technology of the
present application; and
[0026] FIG. 11 is an illustrative flowchart exemplary of one method
of performing operations consistent with the technology of the
present application.
DETAILED DESCRIPTION
[0027] The technology of the present application will now be
described with reference to the attached figures. While the
technology of the present application is described with reference
to measuring a sensory evoked potential from a peripheral nerve in
the wrist such as, for example, the median, or ulnar nerves, one of
ordinary skill in the art will recognize on reading the disclosure
that the technology of the present application may be used to
facilitate stimulating or monitoring of other sites on the scalp,
torso, legs, or the like, such as, for example, the posterior
tibial nerve just posterior to the medial malleolus, or the common
peroneal at the politeal fossa, the median and ulnar nerves at the
wrist as well as over the thenar and hypothenar eminence, and other
innervated muscle groups. For example, it is possible to stimulate
other leg, hand, torso, etc. muscle dermatomes and record a sensory
response, sometimes referred to as dermatome-SEP's or D-SEP's. In
particular, the present application describes the technology in
relation to a garment associated with the hand, wrist, or arm, such
as, for example, a glove, a wrist band, a sleeve, or combination
thereof. Whereas monitoring associated with the legs may use a
garment such as, for example, a stocking or leggings, and
monitoring associated with the head may use a garment such as, for
example, a skull cap or the like. Additionally, other garments may
include multiple pieces such as, for example, a shirt-like
arrangement covering the torso, arms, neck, etc. or a full body
suit as necessary or required. As such, and for convenience, the
technology of the present application will be described with
reference to particular exemplary embodiments. The word "exemplary"
is used herein to mean "serving as an example, instance, or
illustration." Any embodiment described herein as "exemplary" is
not necessarily to be construed as preferred or advantageous over
other embodiments unless specifically indicated as such. Thus, the
examples provided should be considered illustrative of the
technology of the present application and not limiting.
[0028] Referring now to FIG. 3, nerves associated with a typical
arm 30 and hand 32 is provided. The arm 30 and hand 32 have nerves
including the ulnar nerve 34, the median nerve 36, and the radial
nerve 38. During conventional intraoperative monitoring (IOM)
procedures, a needle electrode 40 is inserted through the skin 42
of the arm 30 or hand 32 into muscle tissue 44 and into proximity
with the associated nerve, such as, the ulnar nerve 34 as shown.
Contact should be understood to mean in sufficient proximity for
electrical contact as piercing the nerve with an electrode may have
negative implications including nerve damage. Contact may include
direct contact, but also may include a sufficiently proximate
location to generate an acceptable SEP response at, for example,
sensor 200. A lead 46 electrically couples needle electrode 40 to a
peripheral nerve stimulator 206 as is conventionally known in the
art. The peripheral nerve stimulator, such as, for example, a
single channel constant current stimulus output may provide a
stimulation signal to the monitored nerve. In the exemplary IOM
procedure, the stimulation of the nerve 34 would evoke a
corresponding electrical signal in the brain that may be measured;
in other words,--an evoked potential. Changes in the sensory evoked
potential may facilitate identification of nerve damage as further
explained in co-pending U.S. patent application Ser. No.
12/724,778, titled Somatosensory Evoked Potential (SSEP) Automated
Alert System.
[0029] As can be appreciated, implanting needle electrode 40
requires a certain amount of precision and experience by a
qualified technician. The precision and experience relates to
properly locating the needle electrode 40 at an appropriate portion
of the arm 30 or hand 32, angling the needle electrode 40 at an
appropriate insertion angle .alpha., and inserting the needle
electrode 40 an appropriate amount such that the needle electrode
40 can stimulate the nerve, such as, nerve 34. The technology of
the present application removes some of the experience a technician
would require by providing a garment 50 as shown in FIG. 4. Garment
50 wraps about hand 32 and a portion of arm 30. Garment 50
includes, for example, a palm portion 54, a back of the hand
portion 56 opposite the palm portion 54, a wrist portion 58, and a
thumb portion 60. As shown, garment 50 is a partial glove and wrist
band type of garment, but could be, for example, a complete glove
having a pocket for the fingers or individual finger sleeves. The
fit of the garment 50 provides an orientation of the garment 50
against the hand 32 and a wrist of the arm 30. In this case, for
example, the wrist portion 58 and the thumb portion 60 provide a
particular orientation. Other garments may have other markings and
devices. For example, a legging may have an opening for the knee of
a patient to provide proper orientation. Other garments may have
instructions, such as, for example, a forearm sleeve may indicate
that one opening should be oriented 2 cm from the wrist and the
opposite opening should be oriented 1 cm from the elbow, etc.
[0030] Garment 50 being particularly oriented in relation to
anatomy may be ideally suited to carry other equipment associated
with medical procedures. For example, a sleeve may be loaded not
just with electrodes, but a tube may be used for IV access.
Additionally, blood oxygen sensors may be carried on the garment
and oriented to measure the oxygen level of the blood. Other
medical procedure aids may be provided and the few examples
provided should not be considered limiting.
[0031] Garment 50 being an orientable garment can be marked with
electrode sites 62.sub.1-n of which 4 electrode sites are provided
in the present example and will be further explained below. In this
case, the wrist portion and thumb portion facilitate proper
orientation of the electrode sites 62.sub.1-n. Having multiple
electrode sites also facilitates identifying which of the available
inserted electrodes has the best connectivity between the electrode
and the nerve or muscle being stimulated. Also, in the event one
electrode site was not available due to, for example, an
intravenous arterial line, alternative electrode sites would be
readily available.
[0032] The garment 50 also may have additional markings or gaps as
required by the particular operation that is being performed. For
example, as shown, garment 50 may have an opening 64 in the wrist
portion 58 such that the anesthesiologist, nurse, surgeon or other
personnel may access the arterial line for pharmaceutical
administration or the like. Electrode sites 62.sub.1-n may provide
for needle electrodes, surface electrodes, or other electrodes as
may be known. While the present application is generally described
with respect to needle electrodes, surface electrodes may be
aligned at the electrode sites as required for proper use of the
garment and systems described herein. Moreover, while described as
a single garment, garment 50 may, in fact, be a series of pads or
strips (which are identified by reference number 50s) coupled to
the skin of the patient instead of a unitary garment 50. The pads
may be coupled to the skin of the patient using, for example, an
adhesive or the like. In the event the pads use surface electrodes
instead of needle electrodes, the adhesive may be an electrically
conductive adhesive. To the extent pads were used, the pads would
require more instruction for proper orientation. The instruction
may include pictorial direction, written direction, or a
combination thereof.
[0033] Referring now to FIG. 5, a partial cross sectional view of
the garment 50 is shown about an electrode site 62.sub.1 for
example. Garment 50 may be made out of any number of materials,
such as, for example, a gauze such as a KERLIX.RTM. stretch gauze
glove available from Tyco Healthcare Group LP, a rubber or foam
fabric, a wrap such as a COBAN.RTM. wrap available from 3M Company,
a cloth fabric, a legging such as a T.E.D..RTM. elastic stocking
available from Kendall Company, or the like. Garment 50 should be
capable of manipulation during surgical procedures to allow for
emergencies or the like. For example, after the electrodes are
positioned, garment 50 may be cut away as needed or desired during
the surgical procedure. Garment 50 includes a skin surface 70
adapted to be worn adjacent to the skin 42 and a top surface 72
opposite the skin surface 70. Top surface 72 may have indicia
indicative of electrode sites 62.sub.1-n as shown in FIG. 4.
Garment 50 has a thickness T from the skin surface 70 to the top
surface 72. Residing in garment 50 is a capsule or tube 74. The
tube 74 is shown at an acute angle .alpha., but the angle .alpha.
would be dependent on the nerve being monitored/stimulated. For
example, a low angle may be best for insertion of the needle
electrode proximate the wrist to avoid the needle electrode
actually penetrating the nerve. However, a steeper angle (possibly
even approaching or in fact a 90 degree angle) may be appropriate
for insertion of the needle electrode into the leg, such as for
recording EMG (muscle activity). The needle electrode 40 may be
provided with a lead(s) 46 or lead(s) 46 may be coupled to the
needle electrode 40 just prior to or just after needle electrode 40
is advanced. The tube 74 may be a metal, metal alloy, plastic,
elastomeric, gel material, or other composite of sufficient
rigidity to protect the needle electrode from damage during
operation and use, which includes placing the garment 50 on the
patient. The needle electrode 40 has a distal end 76 adapted to
pierce the skin 42 and advance through tissue until needle
electrode 40 is proximate the appropriate nerve. The needle
electrode 40 also has a proximate end 78 opposite the distal end 76
to which lead or leads 46 may be connected. An actuator 80, such as
a plunger as shown, may be adapted to slidingly engage the tube 74
such that on actuation or depression of the actuator 80, the needle
electrode 40 is advanced. Tube 74 may have a cap 81 or plug 81
about the proximate end 78. To the extent needle electrode 40 is
not preloaded into the tube 74, the cap or plug 81 may facilitate
maintaining tube 74 sterile or clean. The tube 74 may have a stop
82, such as the shoulder as shown, situated in the tube 74 to
provide a positive stop for actuator 80 such that the actuator 80
can only advance the needle electrode 40 the appropriate amount.
Alternatively, the bottom of tube 74 may be the stop. Tube 74 may
have a cover 84 proximate the skin surface 70 of garment 50. Cover
84 at a minimum facilitates maintaining the sterility of the needle
electrode 40. Cover 84 may be a penetratable surface, such as, for
example, a foil, gel, rubber, or the like. Cover 84 may be
relatively flat, as shown in FIG. 5, or bowed slightly, as shown in
phantom in FIG. 8, to facilitate wound closure, as explained more
below. Alternatively, cover 84 may be a cover that moves on
actuation of actuator 80 to allow the needle electrode 40 to
advance. In an exemplary embodiment, the needle electrode advances
into a penetrable material, such as described below with respect to
FIGS. 8 and 9, on the bottom of tube 74 that releases a skin prep
fluid. Also, tube 74 may be threaded such that twisting or rotating
of actuator 80 advances the electrode. The garment 50 may have a
battery (carried in the garment or pluggable into the garment) that
may provide automation of actuator 80. The optional battery may be
used to power the stimulating or recording electrodes as well. The
skin prep fluid may be an antimicrobial fluid that cleans and
disinfects an insertion area prior to the needle electrode
penetrating the skin. The initial advancement of the actuator
advances the needle to penetrate the material and release the
fluid, or other media, for cleaning the skin. As the actuator is
further advanced, the needle electrode is subdermally advanced for
placement proximate the nerve or stimulation site. At the end of
the procedure, the needle electrode is actuated back at least out
of the skin and normally all the way back into tube 74 such that
pressure may be returned to the penetration site to help stop any
bleeding from the needle penetration. To facilitate removing the
needle electrode, a retractor 86 may be operably coupled to
actuator 80 such that as actuator 80 travels from surface 72
towards surface 70, retractor 86 extends from garment 50. At the
termination of the procedure, retractor 86 may be inserted into
garment 50 such that actuator 80, or at least needle electrode 40,
reverses direction and travels toward surface 72 extracting the
needle electrode 40 from the patient. Moreover, cover 84 may move
such that cover 84 covers and applies pressure to the needle
extraction point to inhibit or control bleeding. The garment 50
fitting snugly about the patient may supply sufficient pressure to
inhibit bleeding.
[0034] Referring to FIG. 6, a portion of the tube 74 with the
needle electrode 40 is shown in additional detail. Needle electrode
40 is shown attached to actuator 80. Actuator 80 has a connector 88
into which that lead(s) 46 may plug. Alternatively, connector 88
may be snap fit into a bore 90 in actuator 80. In still another
embodiment, lead(s) 46 may extend through the bore 90 and couple
direct to needle electrode 40. Stop 82 may fit about needle
electrode 40 to provide an insertion guide for needle electrode 40.
In this case, stop 82 may extend to the skin surface 70 as shown in
phantom. Providing a guide would facilitate placement of the needle
electrode 40. The tube 74 is provided with one or more channels 92
in the tube 74. Retractor 86 extends through channel 92 and extends
into needle chamber 94 of tube 74 through a port 96 in channel 92.
Retractor 86 extends towards and couples with actuator 80. As
actuator 80 moves in a direction A to insert needle electrode 40
into a patient, actuator 80 causes retractor 86 to correspondingly
move in a direction B as shown in FIG. 6. On completion of the IOM,
retractor 86 may be moved in a direction opposite to B that would
correspondingly move actuator 80 in a direction opposite to A that
would retract needle electrode 40 from the patient. This is but one
structural example of a means to provide a retracting device on
garment 50. Alternatively, actuator 80 may be under compression
such that pressure (such as air pressure) in tube 74 compresses
actuator 80 to maintain the needle electrode in a retracted state.
For example, actuator 80 may comprise a compression spring between
the plunger and a cap 81 and air pressure in tube 74 between the
plunger and cover 84. As air pressure is bled from tube 74, such
as, for example, out through port 96, the compression spring would
advance the plunger. Thus, the decrease in pressure allows actuator
80 to expand or decompress that tends to advance needle electrode a
certain distance that would correspond to the appropriate
advancement of the needle electrode into the patient. In this case,
the stop may the decompressed spring (i.e., fully advanced). After
the procedure, pressure may be applied to tube 74 through, for
example, port 96 to re-pressurize tube 74 and place actuator 80
under compression. The re-pressurization of tube 74 further may
cause cover 84 to expand, as shown in FIGS. 8 and 9, to apply
additional pressure to the puncture wound associated with the
needle electrode penetrating the skin. Pressure may be applied via
a syringe(s) or compressed air as is generally available in a
hospital O.R.
[0035] While FIGS. 5 and 6 show a needle electrode 40 embedded in
garment 50, the tube 74 may be provided with an opening 95 on top
surface 72. In this case, the needle electrode would be provided
such that it was insertable into the tube 74 from top surface 72
through the cover 84 and skin surface 70. The needle electrode may
extend out of top surface 72 such that pressure may be applied to
the needle electrode 40 to insert or retract the needle electrode
without the need for actuator 80 and retractor 86. The needle
electrode 40 in this embodiment may include a flanged surface 98 to
facilitate a positive stop of the needle electrode 40 when it has
been fully inserted. Alternatively, the needle electrode 40 may
have a flared portion 100 as shown in phantom. In some
applications, advancement of needle electrode 40 may be provided by
a ratchet and pawl mechanism. In this case, for example, tube 74
may have notches 74N and protrusions 74P along tube 74 as shown in
phantom in FIG. 6. The notches 74N would be sized to cooperatively
engage with actuator 80 such that the needle electrode 40 may be
advanced.
[0036] As mentioned above, retraction of the needle may cause
bleeding at the insertion site. In one possible embodiment, the
garment would be provided, with a tight fit to the patient such
that the garment would provide pressure to the wound site to
inhibit bleeding. In some cases, however, the pressure provided by
the garment alone may not be sufficient to satisfactorily promote
clotting and the like. Referring now to FIG. 8, a portion 110 of
tube 74 about cover 84 adjacent skin surface 70 is provided. As
shown, tube 74 may terminate in a cover 84 that may be formed of a
foil or the like. Alternatively, cover 84 may be similar to a
diaphragm, thin rubber material, or the like. Subsequent to
withdrawal of the needle electrode, an air bladder 112 may be
inflated. The air bladder 112 may be inflatable by a placing a
syringe (not specifically shown) in fluid communication with an
intake port 114 on air bladder 112. Inflating the air bladder 112,
or a balloon, provides additional pressure to the wound to
facilitate clotting. A second diaphragm 116 may be used as well.
Second diaphragm 116 is placed away from cover 84 such that air
bladder 112 fills a space 118 between cover 84 and second diaphragm
116. In this case, cover 84 may be more elastic than diaphragm 116
so filling the air bladder causes cover 84 to expand and bow
outward into a convexly curved surface 120 that further facilitates
clotting. Cover 84 may be predesigned with a curved surface 120 as
mentioned above.
[0037] Referring now to FIG. 9, the portion 110 of tube 74 is shown
with cover 84. As mentioned above, cover 84 may be flexible
allowing it to expand to provide the convex surface 112 or cover 84
may be designed with the curved surface 120 to apply pressure to
the wound from the needle electrode 40. A diaphragm 122 above cover
84 defines a chamber 124. The chamber 124 contains a penetrable
material 126 such as, for example, a gel, resin, composite, or the
like through which the needle electrode 40 would extend. The
plastic or composite material should be capable of containing a
skin preparation fluid, such as, for example, a ChloraPrep.RTM.,
such as is available from Medi-Flex Hospital Products Corporation
Kansas, or other antimicrobial fluid as mentioned above.
Collectively the above may be referred to as a cartridge. On
withdrawal of the needle, the cover 84 would supply pressure to the
wound site to facilitate clotting and the penetrable material would
inhibit blood flow through the tube 74.
[0038] As provided above, garment 50 may be provided with multiple
electrodes for any given IOM. Also, once advanced, even a single
needle electrode would need to be tested to ensure the needle has
been advanced and placed adequately to the nerve to be monitored to
allow for proper system operation and the like. With the above in
mind, FIG. 10 provides a flowchart 1000 with an exemplary method to
identify and test placement of one or more needle electrodes 40.
While flowchart 1000 is provided in certain discrete steps, one of
ordinary skill in the art will recognize that the steps identified
may be broken into multiple steps or multiple steps in the
flowchart may be combined into a single step. Moreover, the
sequence of events provided by the flowchart may be altered or
rearranged without departing from the technology of the present
application. In this case, flowchart 1000 relates to placing an
electrode(s) to stimulate the median nerve in the arm/wrist of a
patient and confirming an appropriate or satisfactory evoke
potential from an electrode placed on the scalp or the like. The
process begins by fitting the garment 50 on a patient, step 1002.
Fitting the garment 50 may include adjusting the garment until it
is properly oriented based on the indicia on the garment or
separately provided instructions. Once fitted, oriented, and/or
otherwise adjusted, the needle electrode(s) 40 would be advanced
into the patient, step 1004. Advancing the needle electrode(s) may
include actuating the actuator 80, depressing a plunger,
manipulating a lever, operating a motor such as a stepper motor or
the like, or physically pushing the needle electrode(s) 40 using
hand pressure. If actuator 80 is under compression, advancing the
needle electrode may include bleeding pressure from tube 74. In
either case, the needle electrode(s) 40 are advanced through tube
74 and cover 84 into the patient. The needle electrode(s) may be
advanced up to the mechanical stop in most instances such that the
needle electrode(s) are proximate the associated nerve for
stimulation or muscle intended for recording. In other instances,
however, the needle electrode(s) may not be advanced to the
mechanical stop. Lead(s) 46 would then be used to electrically
couple a peripheral nerve stimulator to the electrode(s) 40, step
1006. A skin surface or subdermal electrode is positioned on the
patient's head, step 1008. For example, a surface electrode may be
placed about 4 cm up and 2 cm back from the top of the patient's
ear. The skin surface or subdermal electrode on the patient's head
is electrically coupled to a display, step 1010. The electrode(s)
40 located at the wrist, leg, etc. are stimulated by the peripheral
nerve stimulator, step 1012, which is received by the electrode on
the patient's head for recording, step 1014. The electrode for
recording transmits a signal to the recording amplifier and may be
displayed on the display, step 1016. The stimulus rate is time
locked to the amplifier average in order to produce the evoked
response. If multiple electrodes 40 are available, each of the
electrodes would be provided with the stimulation signal, in series
or simultaneously. If multiple electrodes 40 are available, it is
next determined which of the available electrodes 40 provides the
best evoked response, step 1018. Determining the best evoked
response may be done visually by observing the evoked responses on
the display. For example, the best evoked response may be the
evoked response that elicits the highest amplitude cortical
response. Alternatively, a processor associated with the display
may automatically determine the electrode 40 that provides the best
evoked response. In another alternative, the impedance of each pair
of electrodes at the wrist may be tested such that the pair with
the lowest and most balanced impedance is selected. In other words,
if only two electrodes available are placed, the system would know
by the impedance that the electrode pair is the pair to stimulate
through. The evoked response from the electrode 40 selected is then
analyzed to determine whether the evoked response is satisfactory,
step 1020. A satisfactory evoked response is generally one that has
acceptable latency, amplitude, and signal to noise parameters. If
the evoked response is satisfactory, which also may be done by
observing the display or automatically determined by the processor,
the surgical procedure may be performed using the needle electrode
40, step 1022. If the best evoked response is not satisfactory, the
garment may be adjusted, the needle electrodes adjusted, or the
like and the process may be repeated until a satisfactory evoked
response is obtained.
[0039] As mentioned above, removal of the electrode(s) 40 may cause
bleeding at the insertion point. In that regard, FIG. 11 provides a
flowchart 1100 with an exemplary method to identify and test
placement of one or more needle electrodes 40. While flowchart 1100
is provided in certain discrete steps, one of ordinary skill in the
art will recognize that the steps identified may be broken into
multiple steps or multiple steps in the flowchart may be combined
into a single step. Moreover, the sequence of events provided by
the flowchart may be altered or rearranged without departing from
the technology of the present application. In this case, after the
surgical procedure is complete and IOM may be discontinued, the
needle electrode(s) 40 are retracted from the patient, step 1102.
The garment 50 is left in place for a sufficient amount of time to
ensure the wound sites clot; step 1104. Optionally, an air bladder
may be inflated using a syringe or the like to apply additional
pressure to the wound, step 1103. Finally, garment 50 is removed
and discarded, step 1106.
[0040] Those of skill in the art would understand that information
and signals may be represented using any of a variety of different
technologies and techniques. For example, data, instructions,
commands, information, signals, bits, symbols, and chips that may
be referenced throughout the above description may be represented
by voltages, currents, electromagnetic waves, magnetic fields or
particles, optical fields or particles, or any combination
thereof.
[0041] Those of skill would further appreciate that the various
illustrative logical blocks, modules, circuits, and algorithm steps
described in connection with the embodiments disclosed herein may
be implemented as electronic hardware, computer software, or
combinations of both. To clearly illustrate this interchangeability
of hardware and software, various illustrative components, blocks,
modules, circuits, and steps have been described above generally in
terms of their functionality. Whether such functionality is
implemented as hardware or software depends upon the particular
application and design constraints imposed on the overall system.
Skilled artisans may implement the described functionality in
varying ways for each particular application, but such
implementation decisions should not be interpreted as causing a
departure from the scope of the present invention.
[0042] The steps of a method or algorithm described in connection
with the embodiments disclosed herein may be embodied directly in
hardware, in a software module executed by a processor, or in a
combination of the two. A software module may reside in Random
Access Memory (RAM), flash memory, Read Only Memory (ROM),
Electrically Programmable ROM (EPROM), Electrically Erasable
Programmable ROM (EEPROM), registers, hard disk, a removable disk,
a CD-ROM, or any other form of storage medium known in the art. An
exemplary storage medium is coupled to the processor such that the
processor can read information from, and write information to, the
storage medium. In the alternative, the storage medium may be
integral to the processor. The processor and the storage medium may
reside in an ASIC. The ASIC may reside in a user terminal. In the
alternative, the processor and the storage medium may reside as
discrete components in a user terminal.
[0043] The previous description of the disclosed embodiments is
provided to enable any person skilled in the art to make or use the
present invention. Various modifications to these embodiments will
be readily apparent to those skilled in the art, and the generic
principles defined herein may be applied to other embodiments
without departing from the spirit or scope of the invention. Thus,
the present invention is not intended to be limited to the
embodiments shown herein but is to be accorded the widest scope
consistent with the principles and novel features disclosed
herein.
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